Product image of Irinotecan Kabi (Irinotecan Hydrochloride Trihydrate) supplied by GNH India

Irinotecan Kabi

Active Ingredient:
Irinotecan Hydrochloride Trihydrate
Origin:
EU

Irinotecan Kabi (Irinotecan Hydrochloride Trihydrate)

Irinotecan Hydrochloride Trihydrate, the active ingredient in Irinotecan Kabi, is a topoisomerase I inhibitor presented as a sterile lyophilized powder for intravenous infusion use. It treats metastatic colorectal cancer in adult patients.
GNH India supplies Irinotecan Kabi as a licensed, GDP‑compliant international pharmaceutical supplier serving oncology centres worldwide.

Manufacturer / TM Owner

Fresenius Kabi España S.A.U.

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Indications & Clinical Uses

Irinotecan Kabi is a topoisomerase I inhibitor used in the management of colorectal cancer.

  • Metastatic colorectal cancer: used in combination chemotherapy regimens to improve overall survival and disease control.

How It Works

  • Irinotecan Hydrochloride Trihydrate is converted intracellularly to its active metabolite SN‑38, which binds to the DNA‑topoisomerase I complex. This stabilises the transient single‑strand breaks introduced during DNA replication, preventing relegation and leading to irreversible DNA damage and cell death in rapidly dividing cancer cells.

Side Effects

Irinotecan Kabi may cause a range of adverse reactions.

Common Side Effects

  • Diarrhea: may be severe and require antidiarrheal therapy.
  • Neutropenia: reduced white blood cell count increasing infection risk.
  • Nausea and vomiting: often managed with antiemetics.
  • Fatigue: general tiredness experienced during treatment.

Serious or Rare Side Effects

  • Febrile neutropenia: fever with low neutrophil count requiring urgent care.
  • Severe colitis or intestinal perforation due to intense diarrhea.
  • Hepatic toxicity: elevated liver enzymes or jaundice.
  • Anaphylactic reactions: rare but potentially life‑threatening hypersensitivity.
  • Tumor lysis syndrome: rapid tumor cell breakdown causing metabolic disturbances.

Precautions & Warnings

Before initiating therapy, clinicians should consider several safety measures.

  • Dose adjustment in hepatic impairment: reduce dose based on bilirubin and liver function tests.
  • Monitor blood counts: perform regular CBC to detect neutropenia early.
  • Assess for diarrhea: initiate prophylactic antidiarrheal agents and educate patients.
  • Avoid concurrent strong CYP3A4 inhibitors: may increase irinotecan exposure and toxicity.
  • Pregnancy and lactation: use only if potential benefit justifies the unknown risk.
  • Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake the product.

Avoid Interactions

Irinotecan can interact with other medicines, affecting its safety and efficacy.

Major Interactions (Avoid)

  • Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole): increase irinotecan plasma levels.
  • UGT1A1 inhibitors (e.g., atazanavir, indinavir): raise SN‑38 exposure and risk of neutropenia.
  • Concurrent myelosuppressive agents (e.g., cyclophosphamide): heighten bone‑marrow suppression.
  • Live vaccines: immunosuppression may lead to uncontrolled infection.

Moderate Interactions (Monitor Closely)

  • CYP3A4 inducers (e.g., rifampin, carbamazepine): may lower drug exposure and reduce efficacy.
  • Warfarin: irinotecan can potentiate anticoagulant effect, requiring INR monitoring.
  • Antacids or supplements containing magnesium/aluminum: may affect absorption of oral formulations (not applicable to IV but noted for completeness).

Frequently Asked Questions

Irinotecan Kabi is an intravenous chemotherapy agent indicated for the treatment of metastatic colorectal cancer. It is typically used as part of combination regimens to improve survival outcomes in adult patients whose disease has spread beyond the colon.

After intravenous administration, Irinotecan is metabolised to SN‑38, which binds to the DNA‑topoisomerase I complex. This prevents the re‑ligation of single‑strand DNA breaks during replication, causing accumulation of DNA damage and ultimately leading to cancer cell death.

The dose of Irinotecan Kabi is determined by the prescribing oncologist based on the patient’s body surface area, liver function, and treatment protocol. Typical regimens involve an intravenous infusion given every two weeks, but exact dosing must be individualized by a qualified healthcare professional.

Safety data for Irinotecan during pregnancy and lactation are limited, and the product is classified as having an unknown pregnancy category. It should only be used when the potential therapeutic benefit justifies any potential risk to the fetus or infant, and breastfeeding is generally not recommended.

To request Irinotecan Kabi, submit an enquiry on the product page at gnhindia.com specifying the required quantity. GNH India supplies hospitals, pharmacies, and procurement teams worldwide, and will verify trade or institutional credentials before providing pricing, availability, shipping details (including cold‑chain logistics if needed), and import documentation.

Irinotecan belongs to the topoisomerase I inhibitor class, differing from agents such as oxaliplatin (a platinum compound) or fluoropyrimidines (e.g., 5‑FU). While all are used in colorectal cancer, Irinotecan’s mechanism targets DNA replication enzymes, offering an alternative resistance profile and often being combined with other agents for synergistic effect.

Irinotecan Kabi should be stored refrigerated at 2‑8 °C, protected from light, and must not be frozen or shaken. Once reconstituted, the solution should be used within the time frame specified in the product labeling and kept under controlled temperature conditions during transport.

The drug is supplied as a sterile lyophilized powder that is reconstituted with a suitable diluent. It is then administered by a qualified healthcare professional as an intravenous infusion over a prescribed period, usually lasting 30 to 90 minutes depending on the treatment protocol.

The most critical adverse events include severe neutropenia or febrile neutropenia, which can lead to life‑threatening infections, and severe diarrhea or colitis that may cause dehydration and electrolyte imbalance. Prompt medical attention is required if fever, persistent diarrhea, or signs of infection develop.

Patients with known hypersensitivity to Irinotecan or any of its excipients should avoid the drug. Individuals with severe hepatic impairment, confirmed UGT1A1 deficiency (e.g., *28/*28 genotype) that predisposes to high SN‑38 exposure, or those currently receiving other myelosuppressive therapies should be evaluated carefully before use.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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